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In order to understand how clinical investigations with medical devices should be conducted, the European Union provides a set of guidelines in the MDR 2017/745 and IVDR 2017/746 regulations for in vitro diagnostic medical devices. ...

There are already 1000 people who follow EpisKey on social networks and who are up to date with all the publications that we launch to better understand what this world is like....

If you manufacture, distribute or have had an idea for a product or software in the health field, you should know whether it is a medical device. Given the large number of definitions in circulation, it is worth considering the one offered by the Spanish Agency...

We tell you what steps you need to take to find out what your medical device looks like, what risk class it falls into and what technical documentation you need to prepare....

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